Developmental Dysplasia of the HipNCT04007016
A New Pelvic Osteotomy Method for Open Reduction
An observational study of Developmental Dysplasia of the Hip, run by Yuxi Su.
Trial summary
Developmental dysplasia of the hip (DDH) was one of the most common hip disorders disease in children. Pemberton osteotomy (PO) was one of the most widely used by the pediatric orthopedic surgeons. In our clinical work, the investigators found some defect the operation procedure. Read more about this study
- Who is it for?
- Ages 2 to 8 years
- Conditions the study is for
- Developmental Dysplasia of the Hip
- What is being tested?
- a new osteotomy from the inner "L shaped" iliac osteotomy
- Type of treatment
- Surgery or procedure
- How many people
- 2 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2016to 1 Jun 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 8 years
- All sexes
- No healthy volunteers
- Child
Study population: All patients were evaluated and treated in the same hospital and the same surgeon did all the operation. The study was carried out between Mar 2016 and May 2018.
Who may be able to join
- over two years old
- open reduction and acetabular osteotomy
- diagnosed as developmental dysplasia of the hip
Who cannot join
- a previous history of DDH surgery
- teratologic dislocations
- cerebral palsy
- other spastic or neuromuscular disease
About this study
Official title: A New Pelvic Osteotomy Method for Open Reduction in the Treatment of Developmental Dysplasia of the Hip in Children
Developmental dysplasia of the hip (DDH) was one of the most common hip disorders disease in children. Pemberton osteotomy (PO) was one of the most widely used by the pediatric orthopedic surgeons. In our clinical work, the investigators found some defect the operation procedure. When the surgeons were not familiar to the PO, it may injured the triradiate cartilage or easily be absorbable of the distal iliac. Here, the investigators found a new pelvic osteotomy just from the inner "L shaped" iliac osteotomy (ILSO) to treat DDH. This approach was in a visible part of the sciatic notch and not presumed to be in the ischium, completely out of sight. Comparing to the PO method, the investigators' operation method was easy to master and had less complications.
- Conditions
- Developmental Dysplasia of the Hip
- Being tested
- a new osteotomy from the inner "L shaped" iliac osteotomy
- Medical subject headings
- Developmental Dysplasia of the Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
a new osteotomy from the inner "L shaped" iliac osteotomyProcedure or surgery
There were two ostectomies were used in the osteotomy. The first was was a cured and 5mm width and the second one was straight 1.5cm width. All the directions was started from the inner to outer just a bove the triradiate cartilage and its shape like"L"
| Study group | Role | What they receive |
|---|---|---|
| Pemberton osteotomy （PO） | PO group received Pemberton osteotomy | |
| inner "L shaped" iliac osteotomy (ILSO) | ILSO group received inner "L shaped" iliac osteotomy Receives: Procedure: a new osteotomy from the inner "L shaped" iliac osteotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
preoperative acetabular index
preoperative acetabular index by measure the postoperative X-ray
Measured: 6th month after surgery
Wiberg's mean center-edge angle
center-edge angle by measure the postoperative X-ray
Measured: 6th month after surgery
Secondary outcomes (2)
blood loss
blood loss during surgery
Measured: 1st day after surgery
avascular necrosis (AVN)
avascular necrosis (AVN) of the femoral head according to the Kalamchi and McEwen classification
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2019
- Study start1 Mar 2016
- Primary completion1 May 2018
- Study completion1 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Developmental Dysplasia of the HipStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yuxi Su
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yuxi Su, Children's Hospital of Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04007016
- Sponsor's protocol ID
- Yuxi-Guoxin 201906
- Status last verified
- Jul 2019
- First submitted
- 28 Jun 2019
- Last updated
- 5 Jul 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A New Pelvic Osteotomy Method for Open Reduction in the Treatment of Developmental Dysplasia of the Hip in Children
- ClinicalTrials.gov ID
- NCT04007016
- Acronym / sponsor ID
- Yuxi-Guoxin 201906
- Conditions
- Developmental Dysplasia of the Hip
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Yuxi SuUniversity, hospital or other
- Study start
- 1 Mar 2016 (actual)
- Primary completion
- 1 May 2018 (actual)
- Study completion
- 1 Jun 2019 (actual)
- First posted
- 5 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Developmental dysplasia of the hip (DDH) was one of the most common hip disorders disease in children. Pemberton osteotomy (PO) was one of the most widely used by the pediatric orthopedic surgeons. In our clinical work, the investigators found some defect the operation procedure. When the surgeons were not familiar to the PO, it may injured the triradiate cartilage or easily be absorbable of the distal iliac. Here, the investigators found a new pelvic osteotomy just from the inner "L shaped" iliac osteotomy (ILSO) to treat DDH. This approach was in a visible part of the sciatic notch and not presumed to be in the ischium, completely out of sight. Comparing to the PO method, the investigators' operation method was easy to master and had less complications.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pemberton osteotomy （PO） | – | –PO group received Pemberton osteotomy |
| inner "L shaped" iliac osteotomy (ILSO) | – | Procedure: a new osteotomy from the inner "L shaped" iliac osteotomyILSO group received inner "L shaped" iliac osteotomy |
Who may qualify
- Ages
- 2 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- All patients were evaluated and treated in the same hospital and the same surgeon did all the operation. The study was carried out between Mar 2016 and May 2018.
Key inclusion criteria (3 listed)
- over two years old
- open reduction and acetabular osteotomy
- diagnosed as developmental dysplasia of the hip
Key exclusion criteria (4 listed)
- a previous history of DDH surgery
- teratologic dislocations
- cerebral palsy
- other spastic or neuromuscular disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| a new osteotomy from the inner "L shaped" iliac osteotomyThere were two ostectomies were used in the osteotomy. The first was was a cured and 5mm width and the second one was straight 1.5cm width. All the directions was started from the inner to outer just a bove the triradiate cartilage and its shape like"L" | Procedure or surgery | inner "L shaped" iliac osteotomy (ILSO) |
Primary outcome
preoperative acetabular index
Time frame: 6th month after surgery
preoperative acetabular index by measure the postoperative X-ray
Wiberg's mean center-edge angle
Time frame: 6th month after surgery
center-edge angle by measure the postoperative X-ray
2 secondary outcomes
blood loss
Time frame: 1st day after surgery
avascular necrosis (AVN)
Time frame: through study completion, an average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Developmental Dysplasia of the Hip, run by Yuxi Su.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
preoperative acetabular index (time frame: 6th month after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2019.